A Study to Assess the Tolerability and Safety of Subcutaneously (SC) Administered Immunoglobulin G (IgG) With Varying Injection Conditions

Genentech

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Immunoglobulin G

Study type: Interventional

Funder types: Industry

Identifiers

NCT07025577

GP45580

Details and patient eligibility

About

This study will evaluate the safety and tolerability of SC administration of IgG in healthy participants.

Enrollment: 82 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body mass index (BMI) 18 to 36 kilograms per meter square (kg/m^2), inclusive
• For females of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during IgG administration and for 28 days after completion of IgG administration
• For males: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm

Exclusion criteria

• Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 28 days after the last study drug administration
• Positive human immunodeficiency virus (HIV) test
• Positive hepatitis B surface antigen or hepatitis B core antibody test
• Positive hepatitis C virus antibody test
• Regular alcohol consumption of >8 drinks/week for females or >12 drinks/week for males
• Poor peripheral venous access
• Major surgical procedure within 28 days prior to initiation of study treatment or anticipation of need for a major surgical procedure during the study
• Known hypersensitivity to IgG or any of its components or to products made with IgG
• History or presence of skin rash or other skin disorders
• Inability to sense pain (e.g., peripheral neuropathy) or have a history of or have been diagnosed with a chronic pain syndrome
• Infection or inflammation of the designated injection site (abdomen)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 4 patient groups

Sequence 1

Experimental group

Description:

Participants will receive SC administrations of IgG into the abdominal region starting with Treatment B, followed by Treatment A.

Treatment:

Drug: Immunoglobulin G

Sequence 2

Experimental group

Description:

Participants will receive SC administrations of IgG into the abdominal region starting with Treatment A, followed by Treatment C.

Treatment:

Drug: Immunoglobulin G

Sequence 3

Experimental group

Description:

Participants will receive SC administrations of IgG into the abdominal region starting with Treatment D, followed by Treatment C.

Treatment:

Drug: Immunoglobulin G

Sequence 4

Experimental group

Description:

Participants will receive SC administrations of IgG into the abdominal region starting with Treatment B, followed by Treatment D.

Treatment:

Drug: Immunoglobulin G